Use of a PCV2 immunogenic composition for lessening clinical symptoms in pigs

Abstract

The present invention relates to the use of an immunogenic composition that comprises a porcine circovirus type 2 (PCV2) antigen for treatment of several clinical manifestations (diseases). Preferably, the clinical manifestations are associated with a PCV2 infection. Preferably, they include lymphadenopathy, lymphoid depletion and/or multinucleated/giant histiocytes. Moreover, the clinical symptoms include lymphadenopathy in combination with one or a multiple of the following symptoms in pigs: (1) interstitial pneumonia with interlobular edema, (2) cutaneous pallor or icterus, (3) mottled atrophic livers, (4) gastric ulcers, (5) nephritis and (6) reproductive disorders, e.g. abortion, stillbirths, mummies, etc. Furthermore the clinical symptoms include Pia like lesions, normally known to be associated with Lawsonia intracellularis infections.

1. A method for lessening and/or reduction of lymphadenopathy in combination with at least one additional symptom selected from the group consisting of: (1) interstitial pneumonia with interlobular edema, (2) cutaneous pallor or icterus, (3) mottled atrophic livers, (4) gastric ulcers, (5) nephritis and (6) reproductive disorders, including abortion, stillbirths, and mummies in pigs, said method comprising the step of administering to a pig a single dose of an immunogenic composition of recombinant PCV2 ORF2 protein and a polymer of acrylic or methacrylic acid to a pig in need thereof, wherein said PCV2 ORF2 protein is present in an amount of 4 μg to 400 μg per dose and wherein lessening and/or reduction of lymphadenopathy in combination with at least one additional symptom is effective after the administration of a single dose of the immunogenic composition and wherein said lessening and/or reduction of lymphadenopathy is in comparison to a pig not receiving said immunogenic composition. 
     
     
       2. The method of  claim 1 , wherein said PCV2 ORF2 protein is
 i) a polypeptide comprising a sequence selected from the group consisting of SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 11; 
 ii) any polypeptide that is at least 90% homologous to the polypeptide of i), 
 iii) a polypeptide that is encoded by a polynucleotide comprising the sequence of SEQ ID NO: 3 or SEQ ID NO: 4, or 
 iv) any polypeptide that is encoded by a polynucleotide that is at least 90% homologous to the polynucleotide of iii). 
 
     
     
       3. The method of  claim 1 , wherein said composition further comprises an additional component selected from the group consisting of inactivated viral vector, cell culture supernate, BEI, sodium thiosulfate, carriers, adjuvants, media, viral inactivators, diluents, isotonic agents, immunomodulatory agents, antibiotics, pharmaceutical acceptable salt, and combinations thereof. 
     
     
       4. The method of  claim 3 , wherein said inactivated viral vector is a recombinant baculovirus coding for the PCV2 ORF2 protein. 
     
     
       5. The method of  claim 1 , wherein said polymer of an acrylic acid or methacrylic acid is cross-linked with polyalkenyl ethers of sugars or polyalcohols. 
     
     
       6. The method of  claim 1 , wherein said polymer of acrylic or methacrylic acid is a carbomer. 
     
     
       7. The method of  claim 6 , wherein said carbomer is included in an amount from about 500 μg to about 5 mg carbomer per dose. 
     
     
       8. The method of  claim 1 , wherein said immunogenic composition is administered to pigs 2 weeks of age or older. 
     
     
       9. The method of  claim 1 , wherein said immunogenic composition is administered to pigs not older than 15 weeks of age. 
     
     
       10. The method of  claim 1 , wherein the single dose of the immunogenic composition is formulated in 1 ml. 
     
     
       11. The method of  claim 1 , wherein the single dose of the immunogenic composition is administered to said pig in 1 ml. 
     
     
       12. The method of  claim 1 , wherein the single dose is retained within a container. 
     
     
       13. The method of  claim 1 , wherein said single dose of said immunogenic composition has 4 μg to 200 μg of recombinant PCV2 ORF2 protein per dose. 
     
     
       14. The method of  claim 1 , wherein said immunogenic composition has 4 μg to 100 μg of recombinant PCV2 ORF2 protein per dose. 
     
     
       15. The method of  claim 1 , wherein said immunogenic composition has 4 μg to 50 μg of recombinant PCV2 ORF2 protein per dose. 
     
     
       16. The method of  claim 1 , wherein said immunogenic composition has 4 μg to 16 μg of recombinant PCV2 ORF2 protein per dose. 
     
     
       17. The method of  claim 1 , wherein only one dose of said immunogenic composition is administered to said pigs.